← Product Code [EZL](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZL) · K961697

# OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE (K961697)

_Medical Device Intl., Inc. · EZL · Aug 30, 1996 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZL/K961697

## Device Facts

- **Applicant:** Medical Device Intl., Inc.
- **Product Code:** [EZL](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZL.md)
- **Decision Date:** Aug 30, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5130
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Therapeutic

## Indications for Use

The OPTICON™ Female Urinary Catheter for Continuous Drainage is used to pass fluids from the urinary bladder. It must be connected to standard drainage tubes, drainage tube adaptors, tubes and bags.

## Device Story

Sterile, single-use, flexible, tubular silicone catheter; 18 French size; 10.8 cm length. Inserted through urethra for continuous bladder drainage. Features microvalve for balloon inflation and retainer ring. Used in clinical settings by healthcare professionals. Connects to standard drainage tube adaptors, tubes, and bags. Facilitates urine passage from urinary tract; aids patient management of urinary retention or incontinence.

## Clinical Evidence

Bench testing only. Device tested to ASTM Standard F623-89, 'Standard Performance Specification for Foley Catheter', meeting all performance requirements.

## Technological Characteristics

Material: Biocompatible silicone. Dimensions: 18 French, 10.8 cm length. Design: Tubular, single-use, balloon-retained. Standards: ASTM F623-89. Sterilization: Sterile.

## Regulatory Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

## Predicate Devices

- Bardex Silicone Foley Catheter ([K760093](/device/K760093.md))
- Rochester Medical Female Uretheral Catheter ([K941692](/device/K941692.md))

## Submission Summary (Full Text)

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AUG 30 1996
K961697

# 510(k) Summary

SUBMITTER: Medical Device International, Inc.

Address: 5116 Birch Road
Minnetonka, MN 55345
Telephone: 612-938-4125

CONTACT PERSON: Greg Sachs
612-938-4125

DATE SUMMARY PREPARED: April 30, 1996

TRADE NAME: OPTICON™ Female Urinary Catheter for Continuous Drainage
COMMON NAME: Foley Catheter
CLASSIFICATION NAME: Urological Catheter

SUBSTANTIALLY EQUIVALENT TO:

The OPTICON™ Female Urinary Catheter for Continuous Drainage is substantially equivalent to the
Bardex Silicone Foley Catheter (K760093) and the Rochester Medical Female Uretheral Catheter
(K941692).

DESCRIPTION of the DEVICE: The OPTICON™ Female Urinary Catheter for Continuous
Drainage is a sterile, single use/disposable, flexible, tubular device that is inserted through the
urethra and is used to pass urine from the urinary tract when connected to standard drainage tube
adaptors, tubes and bags. The catheter is manufactured from soft biocompatible silicone and comes
in only one size (18 French) and length, 10.8 cm (4.3 inches). When inserted, all that is visible
outside of the body is a microvalve for balloon inflation and retainer ring. The device is to be used
only with standard urinary drainage tube adaptors, tubes and bags.

INDICATIONS for USE: The OPTICON™ Female Urinary Catheter for Continuous Drainage is
used to pass fluids from the urinary bladder. It must be connected to standard drainage tubes,
drainage tube adaptors, tubes and bags.

CLINICAL INFORMATION and SAFETY and EFFECTIVENESS:

The OPTICON™ Female Urinary Catheter for Continuous Drainage has been tested to the ASTM
Standard F623-89, "Standard Performance Specification for Foley Catheter" and was found to meet all
performance requirements.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZL/K961697](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZL/K961697)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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